The following data is part of a premarket notification filed by Kvm Technologies, Inc. with the FDA for Therapacer 3000.
Device ID | K925666 |
510k Number | K925666 |
Device Name: | THERAPACER 3000 |
Classification | Exerciser, Powered |
Applicant | KVM TECHNOLOGIES, INC. 9431 WEST SAM HOUSTON PKY. SOUTH Houston, TX 77099 -1882 |
Contact | John F Berry |
Correspondent | John F Berry KVM TECHNOLOGIES, INC. 9431 WEST SAM HOUSTON PKY. SOUTH Houston, TX 77099 -1882 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-10 |
Decision Date | 1993-03-09 |